An interventional study of Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device and Physical therapy and speech therapy/cognitive rehabilitation therapy in Post Concussion Syndrome, sponsored by Neuroscience Group. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Neuroscience Group · Not applicable, Interventional, and Treatment
The goal of this study is to evaluate the efficacy of using sensorimotor multi-axis automated rotational therapy (SMART) to help treat post concussion syndrome (PCS) in adults.
The investigators hypothesize that patients who include SMART therapy as part of their treatment regimen will improve faster than patients who do not include SMART treatment.
The investigators hypothesize that patients whose treatment approach includes SMART will improve to a greater extent in their primary outcome measures than patients whose treatment approach did not include SMART.
The primary study endpoints are Post Concussion Symptom Scale (PCSS), Headache Impact Severity (HIT-6), Neck Disability Index (NDI), Dizziness Handicap Inventory (DHI), Functional Gait Assessment (FGA), Modified Clinical Test of Sensory Interaction in Balance (CTSIB-m), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and the Rivermeade Post-Concussion Symptom Questionnaire. These assessments will be performed before, midway, and after intervention.
Researchers will compare study endpoints to subjects that proceed with standard of care treatments in physical therapy (PT) and speech therapy/cognitive rehabilitation therapy (ST/CRT).
All participants will complete baseline testing in both PT and ST/CRT, and will continue with treatment in each therapy once a week. Intervention subjects will also complete 10 SMART session utilizing GyroStim, at a frequency of 2, 3 or 4 times a week. Follow up testing will happen in PT and ST/CRT after completion of 10 SMART sessions, or during their 6th PT and ST/CRT visit.
Statistical analysis will look compare groups to evaluate efficacy of SMART intervention, as well as evaluate efficacy of therapeutic frequency.
132 studies on the registry are indexed under Post-Concussion Syndrome; 33 are open to participants now.
This study's planned enrollment of 128 is above the median of 52 across 110 interventional studies indexed under Post-Concussion Syndrome.
Browse Post-Concussion Syndrome studies →This is the only study on the registry with Neuroscience Group as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Standard of care treatment for post concussion syndrome. Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week for 5 weeks or 6 total visits.
Other: Physical therapy and speech therapy/cognitive rehabilitation therapy
Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART twice a week for 10 sessions. Last PT \& ST/CRT occur once SMART sessions are completed.
Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device · Other: Physical therapy and speech therapy/cognitive rehabilitation therapy
Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART up to three times a week for 10 sessions. Last PT \& ST/CRT occur once SMART sessions are completed.
Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device · Other: Physical therapy and speech therapy/cognitive rehabilitation therapy
Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART sessions up to four times a week for 10 sessions. Last PT \& ST/CRT occur once SMART sessions are completed.
Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device · Other: Physical therapy and speech therapy/cognitive rehabilitation therapy
GyroStim is a sensorimotor multi-axis automated rotational therapy (SMART) and used to stimulate, challenge, and improve the functional performance of the human sensorimotor system. GyroStim software allows the clinician to select and run specific, individual programs in a series of runs that present incrementally increasing intensity, duration, and cognitive challenge to help promote functional gains and achieve patient rehabilitation. GyroStim consists of a chair that is mounted to two rotational frames that are run by individual electric motors. Each axis can spin up to 360 degrees separately or simultaneously. The chair, rotational frames and pod are enclosed within a circular steel and polycarbonate frame. There are numerous safety features and an integrated targeting system subjects hit with a laser pointer to help integrate visual, vestibular and sensorimotor coordination.
Standard of care for all participants will include physical therapy and speech therapy once a week to address many symptom-based issues that are often associated with post concussion syndrome. Physical therapy will address vestibular, oculomotor, headache, and other muscoloskeletal concerns. Sessions will include patient history, evaluation, assessment, manual therapy, exercises, patient education and home exercise program. Speech therapy will address cognitive concerns which may include communication, memory, and various executive functioning aspects of the brain. Sessions will include patient history, assessment, cognitive tasks and challenges, education and home exercise program.
Headache Impact Test (HIT-6)
Subjective physical therapy questionnaire to evaluate extent of patient's headaches. Scores range from 36-78, with a higher score being more severe.
Time frame: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Post Concussion Symptom Scale (PCSS)
Subjective patient questionnaire evaluating symptoms related to concussion. Scores range from 0-132, with higher scores indicating greater symptom severity.
Time frame: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Dizziness Handicap Inventory (DHI)
Subjective physical therapy questionnaire to evaluate extent and impact of patient's complaints and symptoms of dizziness. Scores range from 0-100, with higher scores indicating greater symptom severity.
Time frame: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Neck Disability Index (NDI)
Subjective physical therapy questionnaire to evaluate the extent and impact of a patient's complaints with neck pain and motion deficits. Scores range from 0-100%, with a higher percentage indicating more severe disability due to neck pain.
Time frame: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Functional Gait Assessment (FGA)
Objective physical therapy assessment to evaluate patient's balance while ambulating. Scores range from 0-30, with high scores indicating a more normal gait, and lower scores indicating abnormality.
Time frame: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Modified Clinical Test of Sensory Interaction in Balance (CTSIB-m)
Objective physical therapy assessment to evaluate a patient's balance while standing. Scoring is based off of time, from 0-120 seconds. The higher the score, the more normal a person's balance.
Time frame: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Objective speech therapy test administered to evaluate patient's extent of cognitive deficits. Scores range from 200-800, and can be interpreted into percentiles. The higher the score, the better the individual's cognitive function.
Time frame: First speech therapy visit and last speech therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Rivermeade Post-Concussion Symptom Questionnaire
Subjective speech therapy questionnaire to evaluate extent of patient's symptoms related to concussion. Scores range from 0-72, with a higher score indicating more severe symptoms.
Time frame: First speech therapy visit and last speech therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
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